BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTION GOLD PROBE BIPOLAR CATHETER

    MDR report key: 1243722 · Received November 25, 2008

    Report

    Report Number
    3005099803-2008-06815
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CAN NOT BE DETERMINED. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE COLONOSCOPY PROCEDURE, THE INJECTION GOLD PROBE BIPOLAR CATHETER TIP BROKE OFF INSIDE THE PATIENT. A ROTH NET WAS USED TO RETRIEVE THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER INJECTION GOLD PROBE BIPOLAR CATHETER. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE BIPOLAR CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560160 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention